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Australian Journal of Pharmacy : September 2006
news news N appeal launched by Medicines Australia (MA) against an Australian Consumer and Competition Council (ACCC) demand, that a register of com- pany entertainment be kept to record all details of pharmaceutical company func- tion expenses associated with educa- tional activity, has steeled the regulator. Sources close to the ACCC told the AJP late last month that it intended to ‘get heavy’ with the industry’s peak body if MA refused to accept the conditions imposed as part of an ongoing voluntary code which was self-administered. ‘The role of the ACCC is to ensure industry compliance with the legislation for which the ACCC has responsibility, and to recommend legislative reform to government where that legislation does not, or cannot, deliver on the legislation’s objectives. ‘Medicines Australia appears to have misunderstood the independent nature of the way in which the ACCC works and the irresistible political force its recommenda- tions have on elected governments. While government may not be instinctively attracted to mandating industry behav- iour, the ACCC, in the past, has not been Code appeal steels competition regulator A By our Canberra Correspondent deterred from proposing strong solutions when it forms the view that public inter- ests are at risk.’ She said that Code breaches had reached a level where the corporate reg- ulator had decided to take a ‘close inter- est’ in determinations reached by an inter- nal MA adjudication committee. This Committee, MA has pointed out on previous occasions, consists of external appointees including consumer represen- tatives, prescribers and lawyers. Medi- cines Australia, under its previous chief executive officer, Kieran Schneemann, had vigorously defended the operation of its Code adjudication process, pointing to the fact that record fines had been levied against members infringing the Code in recent months. However, with the decision to appeal the regulator’s suggested amendments taken at a specially convened meeting in Sydney last month, MA is under mount- ing pressure from members to show that the industry is capable of managing its affairs. There were suggestions that unless the appeal was undertaken, some mem- bers may resign. If this happened, the probable result Upper limit for selenium now higher letters Editor, The Australian Cancer Network1 has recently published a position statement concerning selenium. In part it is indicated there is agreement with advice from the National Health and Medical Research Council that the daily intake of selenium can be revised upwards to 400µg/day. This upper limit of intake [UL] corre- sponds to half the no-observed-adverse— effect level [NOAEL] of 800µg/day. The reference dose [RfD] set by the EPA (USA) is equivalent to 5µg/kg/day of sele- nium; 350µg daily for a 70kg individual. The RfD is defined as ‘an estimate of a daily exposure to the population (includ- ing sensitive subgroups) that is likely to be without any appreciable risk of deleteri- ous effects during a lifetime’.2 In relation to the NOAEL and RfD, Schrauzer points out that these levels of intake can be assumed to apply, primarily, to seleno methionine (high selenium yeast), the major nutritional form of selenium. The daily supranutritional supplement of 200µg of high selenium yeast recom- mended for international cohort cancer trials is well within the limits of the UL set by the NHMRC and the RfD plus an aver- age daily intake of 70 to 90µg/day. 6 ? THE AUSTRALIAN JOURNAL OF PHARMACY VOL 87 SEPTEMBER 2006 would be that the ACCC would take the issue up with the Therapeutic Goods Administration (TGA) as chief industry regulator. The TGA has the power to deregister products of companies found to be in breach of the Code in specific cir- cumstances. It is understood the ACCC may seek to enforce performance from MA members under this provision. A small number of pharmaceutical companies are not members of MA and are, as a result, under scrutiny from ACCC, particularly as a result of a volume of complaints to both MA and the regu- lator. One company, which the ACCC source refused to name, was likely to be used as an example of the Code’s failure to ade- quately regulate behaviour of pharma- ceutical companies on the basis that it was not a member of MA. ‘By not being a member of MA, a com- pany invites special attention on the basis that it may believe it can flout the basic requirements of the Code with impunity,’ the ACCC source said. Legislative action to put the Code under statutory control was an option, the source said. ¦ Apart from very unusual circum- stances, seleno methionine, as high sele- nium yeast, has no role in the treatment of established neoplastic disease. Pharmacists will be pleased that seleno methionine, at these levels of official intake, established after many years of dis- cussion, is not toxic, and ideas of hair falling out and nails falling off can be regarded as a fantasy. J. C. Fitzherbert FRCS Eng Bullangalon Wingello NSW 2579 1. Australian Cancer Network. Ed Kober T, 2006;13:1–10. 2. Schrauzer GN, Nutritional signifi- cance, metabolism and toxicology of seleno methio- nine. Adv Food and Nutr Res 2003;47:73–112.